This invention relates to an external hub used in conjunction with a suture and, in some applications, an internal anchor, for establishing stomas, drains, and so forth, in intra-abdominal viscera, blood vessels, and the like.
The insertion of feeding tubes and drain tubes often require the use of an internal anchor “T-bar” fastener or other fastener which is attached to a tension filament or suture. The fastener is positioned in a blood vessel or organ via a needle, and the opposite end of the suture extends to the outer surface of a patient's skin. In some procedures, this external opposite end of the suture is temporarily stitched to the outer surface of the patient's skin. In other procedures, the external opposite end of the suture is clamped via an external retention device that usually includes a cotton ball, a plastic washer, plastic tubing, and one or more metal crimps. There are problems with both of these external suture retention methods.
Patients dislike having external stitches, which can pull against the skin, or catch on clothing or gowns. Further, additional suturing requires additional skill and safety risks for the physician. Moreover, after external sutures are in place, there may be confusion as to why the sutures are present. There is a risk that a health care provider, as a result of this confusion, will try to cut and pull out the external suture(s). Issues also exist with retention devices.
One retention device, described above, has many drawbacks. It cannot easily be cleaned. That is, the cotton ball, which is positioned against the patient's skin, may easily harbor bacteria and microorganisms, and may be difficult to change. Further, the device uses plastic tubing, washers, and metal crimps. The combination of components in this retention device results in a high profile away from the skin, typically 0.75 inches or more. These devices may pull, catch on clothing, or rub against the skin, causing abrasion or necrosis due to pressure.
There exists a need for a suture retention hub that has a low profile against a patient's skin. Such a device would be easily recognizable to health care workers as a retention hub for anchoring an internally disposed device via a suture. The hub would desirably by formed at least partially from a material which has excellent biocompatibility and ease of cleaning. Such a material would desirably be soft and provide cushioning against a patient's skin, to prevent abrasion and/or necrosis. Such a hub would permit an adequate retention force, and desirably would permit easy application of tension on the suture by a simple manipulation of the hub.